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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92688

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 18, 2023
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Abbott Medical

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Z-2505-2023
Recall number
Z-2505-2023
Initiated
July 18, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Abbott Medical
Quantity
113,784 devices (U.S.-95,226; OUS-18558)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Code information

Model Number: 3660 UDI-DI Codes: 05415067031419 05415067020192 Serial Numbers: US AAD154.1 AAD159.1 AAD161.1 AAD172.1 AAD197.1 AAD199.1 AAD200.1 AAD206.1 AAD211.1 AAD214.1 AAD219.1 AAD222.1 AAD230.1 AAD232.1 AAD235.1 AAD240.1 AAD241.1 AAD246.1 AAD248.1 AAD252.1 AAD260.1 AAD268.1 AAD269.1 AAD274.1 AAD282.1 AAD284.1 AAD286.1 AAD291.1 AAD292.1 AAD303.1 AAD304.1 AAD305.1 AAD306.1 AAD311.1 AAD312.1 AAD317.1 AAD321.1 AAD334.1 AAD337.1 AAD341.1 AAD343.1 AAD358.1 AAD361.1 AAD363.1 AAD364.1 AAD366.1 AAD369.1 AAD370.1 AAD374.1 AAD378.1 AAD382.1 AAN928.1 AAN929.1 AAN930.1 AAN931.1 AAN932.1 AAN935.1 AAN937.1 AAN942.1 AAN945.1 AAN949.1 AAN950.1 AAN956.1 AAN961.1 AAN966.1 AAN967.1 AAN972.1 AAN978.1 AAN979.1 AAN983.1 AAN985.1 AAN986.1 AAN992.1 AAN994.1 AAN999.1 AAP002.1 AAP003.1 AAP012.1 AAP021.1 AAP027.1 AAP037.1 AAP039.1 AAP041.1 AAP042.1 AAP051.1 AAP058.1 AAP064.1 AAP065.1 AAP068.1 AAP071.1 AAP073.1 AAP074.1 AAP084.1 AAP086.1 AAP087.1 AAP091.1 AAP098.1 AAP101.1 AAP105.1 AAP110.1 AAP112.1 AAP123.1 AAP128.1 AAP130.1 AAP131.1 AAP136.1 AAP138.1 AAP141.1 AAP142.1 AAP143.1 AAP145.1 AAP151.1 AAP154.1 AAP155.1 AAP156.1 AAP158.1 AAP161.1 AAP163.1 AAP169.1 AAP170.1 AAP171.1 AAP181.1 AAP184.1 AAP204.1 AAP206.1 AAP210.1 AAP222.1 AAP232.1 AAP240.1 AAP241.1 AAP245.1 AAP247.1 AAP248.1 AAP249.1 AAP257.1 AAP258.1 AAP262.1 AAP265.1 AAP272.1 AAP284.1 AAP287.1 AAP296.1 AAP304.1 AAP306.1 AAP309.1 AAP312.1 AAP316.1 AAP317.1 AAP320.1 AAP322.1 AAP323.1 AAP335.1 AAP337.1 AAP340.1 AAP341.1 AAP343.1 AAP344.1 AAP348.1 AAP349.1 AAP357.1 AAP360.1 AAP370.1 AAP378.1 AAP379.1 AAP383.1 AAP384.1 AAP388.1 AAP404.1 AAP405.1 AAP406.1 AAP408.1 AAT455.1 AAT456.1 AAT464.1 AAT466.1 AAT467.1 AAT471.1 AAT489.1 AAT494.1 AAT495.1 AAT502.1 AAT503.1 AAT511.1 AAT515.1 AAT517.1 AAT519.1 AAT521.1 AAT524.1 AAT525.1 AAT526.1 AAT527.1 AAT529.1 AAT531.1 AAT536.1 AAT537.1 AAT539.1 AAT541.1 AAT544.1 AAT548.1 AAT550.1 AAT563.1 AAT569.1 AAT570.1 AAT574.1 AAT578.1 AAT583.1 AAT598.1 AAT600.1 AAT601.1 AAT602.1 AAT606.1 AAT609.1 AAT615.1 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ABM395.1 ABM410.1 ABM413.1 ABM422.1 ABM425.1 ABM430.1 ABM434.1 ABM443.1 ABM444.1 ABM445.1 ABM446.1 ABM448.1 ABM450.1 ABM451.1 ABM452.1 ABM455.1 ABM457.1 ABM461.1 ABM463.1 ABM464.1 ABM465.1 ABM467.1 ABM474.1 ABM477.1 ABM481.1 ABM484.1 ABM489.1 ABM490.1 ABM491.1 ABM492.1 ABM493.1 ABM494.1 ABM498.1 ABM500.1 ABM501.1 ABM502.1 ABM503.1 ABM505.1 ABM506.1 ABM508.1 ABM510.1 ABM512.1 ABM519.1 ABM521.1 ABM527.1 ABM528.1 ABM530.1 ABM532.1 ABM533.1 ABM536.1 ABM542.1 ABM552.1 ABM553.1 ABM558.1 ABM563.1 ABM565.1 ABM570.1 ABM572.1 ABM574.1 ABM579.1 ABM588.1 ABM591.1 ABM594.1 ABM595.1 ABM597.1 ABM602.1 ABM603.1 ABM604.1 ABM607.1 ABM608.1 ABM612.1 ABM613.1 ABM615.1 ABM617.1 ABM625.1 ABM627.1 ABM629.1 ABM631.1 ABM636.1 ABM637.1 ABM638.1 ABM641.1 ABM642.1 ABM644.1 ABM646.1 ABM649.1 ABM653.1 ABM655.1 ABM657.1 ABT683.1 ABT685.1 ABT686.1 ABT690.1 ABT693.1 ABT695.1 ABT700.1 ABT702.1 ABT717.1 ABT726.1 ABT727.1 ABT735.1 ABT738.1 ABT742.1 ABT748.1 ABT751.1 ABT752.1 ABT760.1 ABT762.1 ABT763.1 ABT768.1 ABT771.1 ABT774.1 ABT778.1 ABT784.1 ABT786.1 ABT788.1 ABT789.1 ABT791.1 ABT795.1 ABT796.1 ABT804.1 ABT810.1 ABT817.1 ABT820.1 ABT821.1 ABT824.1 ABT825.1 ABT830.1 ABT835.1 ABT836.1 ABT837.1 ABT838.1 ABT840.1 ABT846.1 ABT849.1 ABT851.1 ABT853.1 ABT861.1 ABT863.1 ABT866.1 ABT869.1 ABT870.1 ABT871.1 ABT872.1 ABT880.1 ABT881.1 ABT882.1 ABT885.1 ABT888.1 ABT893.1 ABT894.1 ABT897.1 ABT903.1 ABT908.1 ABT917.1 ABT918.1 ABT920.1 ABT921.1 ABT924.1 ABT928.1 ABT929.1 ABT935.1 ABT938.1 ABT946.1 ABT950.1 ABT953.1 ABT955.1 ABT958.1 ABT959.1 ABT960.1 ABT965.1 ABT968.1 ABT969.1 ABT970.1 ABT974.1 ABT977.1 ABT979.1 ABT985.1 ABT986.1 ABT988.1 ABU001.1 ABU002.1 ABU007.1 ABU010.1 ABU013.1 ABU015.1 ABU017.1 ABU022.1 ABU023.1 ABU027.1 ABU030.1 ABU031.1 ABU033.1 ABU034.1 ABU045.1 ABU047.1 ABU048.1 ABU050.1 ABU051.1 ABU052.1 ABU053.1 ABU060.1 ABU062.1 ABU064.1 ABU065.1 ABU073.1 ABU075.1 ABU083.1 ABU085.1 ABU092.1 ABU094.1 ABU095.1 ABU097.1 ABU101.1 ABU102.1 ABU105.1 ABU108.1 ABU110.1 ABU113.1 ABU114.1 ABU115.1 ABU116.1 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AGM734.1 AGM735.1 AGM738.1 AGM762.1 AGM767.1 AGM770.1 AGM777.1 AGM779.1 AGM781.1 AGM786.1 AGM792.1 AGM795.1 AGM799.1 AGM800.1 AGM801.1 AGM802.1 AGM807.1 AGM810.1 AGM811.1 AGM812.1 AGM814.1 AGM815.1 AGM817.1 AGM819.1 AGM822.1 AGM829.1 AGM830.1 AGM834.1 AGM836.1 AGM837.1 AGM840.1 AGM847.1 AGM849.1 AGM853.1 AGM861.1 AGM863.1 AGM868.1 AGM869.1 AGM880.1 AGM884.1 AGM887.1 AGM888.1 AGM893.1 AGM894.1 AGM895.1 AGM899.1 AGM908.1 AGM910.1 AGM911.1 AGM920.1 AGM922.1 AGM923.1 AGM929.1 AGM930.1 AGM933.1 AGM935.1 AGM936.1 AGM943.1 AGM947.1 AGM948.1 AGM949.1 AGM961.1 AGM962.1 AGM963.1 AGM966.1 AGM967.1 AGM968.1 AGM975.1 AGM976.1 AGM977.1 AGM979.1 AGM980.1 AGM981.1 AGM984.1 AGM986.1 AGM987.1 AGM990.1 AGM994.1 AGN014.1 AGN015.1 AGN023.1 AGN025.1 AGN028.1 AGN037.1 AGN039.1 AGN043.1 AGN044.1 AGN045.1 AGN048.1 AGN049.1 AGN050.1 AGN051.1 AGN053.1 AGN059.1 AGN060.1 AGN063.1 AGN072.1 AGN076.1 AGN078.1 AGN083.1 AGN084.1 AGN085.1 AGN086.1 AGN092.1 AGN094.1 AGN096.1 AGN097.1 AGN099.1 AGN101.1 AGN107.1 AGN108.1 AGN109.1 AGN112.1 AGN113.1 AGN118.1 AGN119.1 AGN120.1 AGN122.1 AGN123.1 AGN124.1 AGN125.1 AGN127.1 AGN131.1 AGN135.1 AGN138.1 AGN139.1 AGN141.1 AGN145.1 AGN146.1 AGN147.1 AGN148.1 AGN151.1 AGN152.1 AGN153.1 AGN154.1 AGN159.1 AGN163.1 AGN169.1 AGN174.1 AGN177.1 AGN179.1 AGN180.1 AGN181.1 AGN182.1 AGN187.1 AGN191.1 AGN193.1 AGN194.1 AGN196.1 AGN197.1 AGN200.1 AGN204.1 AGN210.1 AGN212.1 AGN213.1 AGN217.1 AGN218.1 AGN221.1 AGN226.1 AGN228.1 AGN233.1 AGN234.1 AGN241.1 AGN242.1 AGN246.1 AGN248.1 AGN254.1 AGN257.1 AGN258.1 AGN261.1 AGN264.1 AGN267.1 AGN269.1 AGN272.1 AGN274.1 AGN275.1 AGN277.1 AGN278.1 AGN287.1 AGN289.1 AGN292.1 AGN297.1 AGN298.1 AGN301.1 AGN304.1 AGN312.1 AGN313.1 AGN317.1 AGN318.1 AGN319.1 AGN321.1 AGN329.1 AGN330.1 AGN333.1 AGN334.1 AGN342.1 AGN345.1 AGN346.1 AGN351.1 AGN353.1 AGN356.1 AGN359.1 AGN366.1 AGN367.1 AGN368.1 AGN370.1 AGN372.1 AGN373.1 AGN379.1 AGN380.1 AGN382.1 AGN386.1 AGN388.1 AGN392.1 AGN397.1 AGN398.1 AGN401.1 AGN402.1 AGN403.1 AGN405.1 AGN407.1 AGN408.1 AGN411.1 AGN412.1 AGN413.1 AGN414.1 AGN415.1 AGN417.1 AGN422.1 AGN424.1 AGN427.1 AGN428.1 AGN431.1 AGN432.1 AGN439.1 AGN441.1 AGN442.1 AGN443.1 AGN444.1 AGN445.1 AGN446.1 AGN451.1 AGN453.1 AGN455.1 AGN457.1 AGN458.1 AGN464.1 AGN471.1 AGN472.1 AGN475.1 AGN481.1 AGN482.1 AGN483.1 AGN484.1 AGN486.1 AGN487.1 AGN488.1 AGN489.1 AGN491.1 AGN492.1 AGN496.1 AGN497.1 AGN498.1 AGN499.1 AGN501.1 AGN505.1 AGN507.1 AGN511.1 AGN513.1 AGN515.1 AGN517.1 AGN519.1 AGN521.1 AGN524.1 AGN525.1 AGN527.1 AGN529.1 AGN530.1 AGN531.1 AGN533.1 AGN534.1 AGN537.1 AGN539.1 AGN540.1 AGN543.1 AGN544.1 AGN548.1 AGN556.1 AGN557.1 AGN558.1 AGN561.1 AGN563.1 AGN564.1 AGN566.1 AGN568.1 AGN569.1 AGN570.1 AGN571.1 AGN574.1 AGN575.1 AGN577.1 AGN578.1 AGN579.1 AGN581.1 AGN585.1 AGN589.1 AGN590.1 AGN591.1 AGN593.1 AGN594.1 AGN597.1 AGN599.1 AGN602.1 AGN604.1 AGN606.1 AGN607.1 AGN608.1 AGN610.1 AGN611.1 AGN613.1 AGN615.1 AGN622.1 AGU276.1 AGU282.1 AGU285.1 AGU288.1 AGU289.1 AGU292.1 AGU296.1 AGU297.1 AGU304.1 AGU306.1 AGU308.1 AGU312.1 AGU317.1 AGU320.1 AGU321.1 AGU324.1 AGU325.1 AGU326.1 AGU327.1 AGU331.1 AGU333.1 AGU335.1 AGU338.1 AGU341.1 AGU342.1 AGU345.1 AGU346.1 AGU347.1 AGU349.1 AGU350.1 AGU351.1 AGU355.1 AGU360.1 AGU361.1 AGU363.1 AGU364.1 AGU366.1 AGU368.1 AGU369.1 AGU370.1 AGU372.1 AGU374.1 AGU375.1 AGU376.1 AGU377.1 AGU378.1 AGU379.1 AGU381.1 AGU386.1 AGU387.1 AGU388.1 AGU389.1 AGU390.1 AGU393.1 AGU394.1 AGU396.1 AGU398.1 AGU401.1 AGU402.1 AGU404.1 AGU409.1 AGU410.1 AGU413.1 AGU415.1 AGU416.1 AGU417.1 AGU421.1 AGU422.1 AGU424.1 AGU427.1 AGU428.1 AGU429.1 AGU430.1 AGU431.1 AGU432.1 AGU433.1 AGU434.1 AGU435.1 AGU438.1 AGU439.1 AGU440.1 AGU444.1 AHD570.1 AHD574.1 AHD579.1 AHD581.1 AHD594.1 AHD596.1 AHD602.1 AHD604.1 AHD608.1 AHD609.1 AHD611.1 AHD614.1 AHD615.1 AHD616.1 AHD620.1 AHD623.1 AHD624.1 AHD625.1 AHD627.1 AHD628.1 AHD629.1 AHD630.1 AHD632.1 AHD634.1 AHD636.1 AHD637.1 AHD638.1 AHD639.1 AHD640.1 AHD641.1 AHD643.1 AHD645.1 AHD647.1 AHD650.1 AHD651.1 AHD652.1 AHD653.1 AHD656.1 AHD659.1 AHD665.1 AHD667.1 AHD688.1 AHD691.1 AHD697.1 AHD699.1 AHD700.1 AHD702.1 AHD703.1 AHD706.1 AHD708.1 AHD716.1 AHD717.1 AHD721.1 AHD723.1 AHD728.1 AHD731.1 AHD732.1 AHD734.1 AHD738.1 AHD740.1 AHD741.1 AHD746.1 AHD747.1 AHD754.1 AHD762.1 AHD771.1 AHD773.1 AHD774.1 AHD777.1 AHD778.1 AHD782.1 AHD802.1 AHD804.1 AHD811.1 AHD812.1 AHD813.1 AHD815.1 AHD820.1 AHD824.1 AHD826.1 AHD828.1 AHD831.1 AHD833.1 AHD834.1 AHD838.1 AHD843.1 AHD844.1 AHD850.1 AHD853.1 AHD855.1 AHD856.1 AHD859.1 AHD862.1 AHD863.1 AHD868.1 AHD874.1 AHD886.1 AHK481.1 AHK487.1 AHK494.1 AHK496.1 AHK499.1 AHK500.1 AHK501.1 AHK502.1 AHK523.1 AHK525.1 AHK535.1 AHK550.1 AHK558.1 AHK571.1 AHK580.1 AHK598.1 AHK600.1 AHK602.1 AHK606.1 AHK607.1 AHK630.1 AHK631.1 AHK640.1 AHK648.1 AHK650.1 AHK654.1 AHK662.1 AHK671.1 AHK674.1 AHK675.1 AHK678.1 AHK691.1 AHK696.1 AHK702.1 AHK708.1 AHK716.1 AHK721.1 AHK723.1 AHK728.1 AHK730.1 AHK740.1 AHK749.1 AHK753.1 AHK758.1 AHK759.1 AHK760.1 AHK766.1 AHK776.1 AHK780.1 AHK799.1 AHK815.1 AHK832.1 AHK840.1 AHK843.1 AHK855.1 AHK858.1 AHK859.1 AHK861.1 AHK862.1 AHK865.1 AHK867.1 AHK871.1 AHK872.1 AHK873.1 AHK878.1 AHK880.1 AHK882.1 AHK887.1 AHK889.1 AHK894.1 AHK896.1 AHK901.1 AHK904.1 AHK907.1 AHK910.1 AHK911.1 AHK913.1 AHK914.1 AHK919.1 AHK924.1 AHK925.1 AHK927.1 AHK930.1 AHK932.1 AHK933.1 AHK945.1 AHK956.1 AHK960.1 AHK963.1 AHK964.1 AHK966.1 AHK974.1 AHK980.1 AHK981.1 AHK982.1 AHK985.1 AHK987.1 AHK989.1 AHK991.1 AHK995.1 AHK996.1 AHL003.1 AHL009.1 AHL014.1 AHL017.1 AHL021.1 AHL026.1 AHL029.1 AHL030.1 AHL040.1 AHL041.1 AHL043.1 AHL044.1 AHL045.1 AHL048.1 AHL052.1 AHL055.1 AHL057.1 AHL059.1 AHL061.1 AHL062.1 AHL063.1 AHL067.1 AHL068.1 A

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 2 of 7

Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Z-2506-2023
Recall number
Z-2506-2023
Initiated
July 18, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Abbott Medical
Quantity
41,745 devices (US-32,782, OUS-8,963)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Code information

Model Number: 3662 UDI-DI Codes: 05415067031426 05415067020222 Serial Numbers: US AAD135.1 AAD136.1 AAD137.1 AAD139.1 AAD141.1 AAD145.1 AAD153.1 AAD158.1 AAD162.1 AAD164.1 AAD165.1 AAD166.1 AAD170.1 AAD171.1 AAD173.1 AAD174.1 AAD176.1 AAD178.1 AAD179.1 AAD181.1 AAD182.1 AAD186.1 AAD191.1 AAD196.1 AAD198.1 AAD205.1 AAD209.1 AAD215.1 AAD217.1 AAD221.1 AAD225.1 AAD226.1 AAD228.1 AAD234.1 AAD236.1 AAD237.1 AAD238.1 AAD242.1 AAD243.1 AAD263.1 AAD265.1 AAD275.1 AAD277.1 AAD278.1 AAD287.1 AAD288.1 AAD289.1 AAD290.1 AAD293.1 AAD296.1 AAD307.1 AAD319.1 AAD324.1 AAD325.1 AAD326.1 AAD331.1 AAD335.1 AAD336.1 AAD338.1 AAD344.1 AAD349.1 AAD351.1 AAD354.1 AAD360.1 AAD362.1 AAD368.1 AAD371.1 AAD375.1 AAD383.1 AAN922.1 AAN926.1 AAN936.1 AAN943.1 AAN944.1 AAN955.1 AAN958.1 AAN960.1 AAN963.1 AAN969.1 AAN973.1 AAN980.1 AAN982.1 AAN984.1 AAN987.1 AAN990.1 AAN991.1 AAN993.1 AAN998.1 AAP004.1 AAP008.1 AAP010.1 AAP011.1 AAP013.1 AAP014.1 AAP018.1 AAP020.1 AAP023.1 AAP024.1 AAP025.1 AAP029.1 AAP032.1 AAP034.1 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AFG531.1 AFG533.1 AFG537.1 AFG538.1 AFG540.1 AFG542.1 AFG543.1 AFG546.1 AFG548.1 AFG549.1 AFG550.1 AFG551.1 AFG552.1 AFG554.1 AFG555.1 AFG556.1 AFG557.1 AFG559.1 AFG562.1 AFG563.1 AFG566.1 AFG568.1 AFG570.1 AFG572.1 AFG573.1 AFG575.1 AFG579.1 AFG581.1 AFG583.1 AFG584.1 AFG585.1 AFG586.1 AFG588.1 AFG592.1 AFG593.1 AFG594.1 AFG597.1 AFG598.1 AFG599.1 AFG600.1 AFG602.1 AFG605.1 AFG608.1 AFG609.1 AFG610.1 AFG611.1 AFG612.1 AFG617.1 AFG618.1 AFG619.1 AFG623.1 AFG624.1 AFG625.1 AFG628.1 AFG629.1 AFG630.1 AFG632.1 AFG633.1 AFG635.1 AFG636.1 AFG638.1 AFG639.1 AFG641.1 AFG642.1 AFG647.1 AFG650.1 AFG651.1 AFG654.1 AFG657.1 AFG659.1 A

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 3 of 7

Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Z-2507-2023
Recall number
Z-2507-2023
Initiated
July 18, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Abbott Medical
Quantity
2,242 device (US only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Code information

Model Number: 3670 UDI-DI Codes: 05415067046383 Serial Numbers: US AAD135.1 AAD136.1 AAD137.1 AAD139.1 AAD141.1 AAD145.1 AAD153.1 AAD158.1 AAD162.1 AAD164.1 AAD165.1 AAD166.1 AAD170.1 AAD171.1 AAD173.1 AAD174.1 AAD176.1 AAD178.1 AAD179.1 AAD181.1 AAD182.1 AAD186.1 AAD191.1 AAD196.1 AAD198.1 AAD205.1 AAD209.1 AAD215.1 AAD217.1 AAD221.1 AAD225.1 AAD226.1 AAD228.1 AAD234.1 AAD236.1 AAD237.1 AAD238.1 AAD242.1 AAD243.1 AAD263.1 AAD265.1 AAD275.1 AAD277.1 AAD278.1 AAD287.1 AAD288.1 AAD289.1 AAD290.1 AAD293.1 AAD296.1 AAD307.1 AAD319.1 AAD324.1 AAD325.1 AAD326.1 AAD331.1 AAD335.1 AAD336.1 AAD338.1 AAD344.1 AAD349.1 AAD351.1 AAD354.1 AAD360.1 AAD362.1 AAD368.1 AAD371.1 AAD375.1 AAD383.1 AAN922.1 AAN926.1 AAN936.1 AAN943.1 AAN944.1 AAN955.1 AAN958.1 AAN960.1 AAN963.1 AAN969.1 AAN973.1 AAN980.1 AAN982.1 AAN984.1 AAN987.1 AAN990.1 AAN991.1 AAN993.1 AAN998.1 AAP004.1 AAP008.1 AAP010.1 AAP011.1 AAP013.1 AAP014.1 AAP018.1 AAP020.1 AAP023.1 AAP024.1 AAP025.1 AAP029.1 AAP032.1 AAP034.1 AAP040.1 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AFG327.1 AFG328.1 AFG329.1 AFG333.1 AFG334.1 AFG335.1 AFG336.1 AFG337.1 AFG338.1 AFG339.1 AFG340.1 AFG341.1 AFG342.1 AFG343.1 AFG345.1 AFG348.1 AFG351.1 AFG352.1 AFG353.1 AFG354.1 AFG357.1 AFG359.1 AFG360.1 AFG361.1 AFG364.1 AFG365.1 AFG366.1 AFG367.1 AFG368.1 AFG371.1 AFG372.1 AFG373.1 AFG375.1 AFG377.1 AFG378.1 AFG381.1 AFG382.1 AFG383.1 AFG385.1 AFG386.1 AFG395.1 AFG396.1 AFG398.1 AFG401.1 AFG402.1 AFG405.1 AFG406.1 AFG408.1 AFG409.1 AFG410.1 AFG416.1 AFG417.1 AFG421.1 AFG423.1 AFG427.1 AFG428.1 AFG430.1 AFG433.1 AFG434.1 AFG435.1 AFG438.1 AFG439.1 AFG441.1 AFG442.1 AFG444.1 AFG448.1 AFG449.1 AFG453.1 AFG455.1 AFG458.1 AFG459.1 AFG460.1 AFG461.1 AFG462.1 AFG463.1 AFG470.1 AFG478.1 AFG479.1 AFG480.1 AFG481.1 AFG483.1 AFG484.1 AFG486.1 AFG490.1 AFG491.1 AFG492.1 AFG493.1 AFG494.1 AFG497.1 AFG499.1 AFG500.1 AFG502.1 AFG506.1 AFG508.1 AFG510.1 AFG511.1 AFG512.1 AFG513.1 AFG514.1 AFG516.1 AFG517.1 AFG518.1 AFG519.1 AFG521.1 AFG522.1 AFG523.1 AFG524.1 AFG525.1 AFG526.1 AFG530.1 AFG531.1 AFG533.1 AFG537.1 AFG538.1 AFG540.1 AFG542.1 AFG543.1 AFG546.1 AFG548.1 AFG549.1 AFG550.1 AFG551.1 AFG552.1 AFG554.1 AFG555.1 AFG556.1 AFG557.1 AFG559.1 AFG562.1 AFG563.1 AFG566.1 AFG568.1 AFG570.1 AFG572.1 AFG573.1 AFG575.1 AFG579.1 AFG581.1 AFG583.1 AFG584.1 AFG585.1 AFG586.1 AFG588.1 AFG592.1 AFG593.1 AFG594.1 AFG597.1 AFG598.1 AFG599.1 AFG600.1 AFG602.1 AFG605.1 AFG608.1 AFG609.1 AFG610.1 AFG611.1 AFG612.1 AFG617.1 AFG618.1 AFG619.1 AFG623.1 AFG624.1 AFG625.1 AFG628.1 AFG629.1 AFG630.1 AFG632.1 AFG633.1 AFG635.1 AFG636.1 AFG638.1 AFG639.1 AFG641.1 AFG642.1 AFG647.1 AFG650.1 AFG651.1 AFG654.1 AFG657.1 AFG659.1 AFG660.1 AFG661.

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 4 of 7

Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Z-2508-2023
Recall number
Z-2508-2023
Initiated
July 18, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Abbott Medical
Quantity
387 devices (US only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Code information

Model Number: 3672 UDI-DI Codes: 05415067046406 Serial Numbers: US CBW328.1 CCA167.1 CCA177.1 CCU613.1 CCV760.1 CCX700.1 CCY890.1 CDR307.1 CDW220.1 CEC548.1 CEC719.1 CEE095.1 CEH111.1 CEH156.1 CEH200.1 CEH272.1 CEH293.1 CEH334.1 CEH964.1 CEH975.1 CEH993.1 CEK127.1 CEK258.1 CEK265.1 CEK271.1 CEK310.1 CEK432.1 CEM232.1 CEM340.1 CEM349.1 CEM375.1 CEM383.1 CEM396.1 CEN429.1 CEN444.1 CEP494.1 CEP497.1 CEP537.1 CEP540.1 CEP541.1 CEP553.1 CEP554.1 CEP562.1 CEP585.1 CEP645.1 CEP658.1 CEP663.1 CEP671.1 CEP685.1 CEP725.1 CEP730.1 CEP838.1 CEP847.1 CEP867.1 CER393.1 CER395.1 CER462.1 CER482.1 CER509.1 CER576.1 CET134.1 CET147.1 CET298.1 CET336.1 CET343.1 CET649.1 CEY608.1 CEY648.1 CFL299.1 CFL403.1 CFL540.1 CFL582.1 CFP963.1 CFP987.1 CFP991.1 CFR079.1 CFR100.1 CFR121.1 CFR392.1 CFR446.1 CFR478.1 CFR585.1 CFU079.1 CFU082.1 CFU091.1 CFU097.1 CFU098.1 CFU099.1 CFU121.1 CFU126.1 CFU132.1 CFU145.1 CFU333.1 CFU401.1 CFU426.1 CFU441.1 CFU460.1 CFU467.1 CFU472.1 CFU483.1 CFU526.1 CFU547.1 CFU569.1 CFU646.1 CFU687.1 CFV457.1 CFV588.1 CFV718.1 CFX211.1 CGA013.1 CGA029.1 CGA065.1 CGA097.1 CGA145.1 CGA331.1 CGA365.1 CGA406.1 CGA426.1 CGA451.1 CGA491.1 CGA500.1 CGA515.1 CGA581.1 CGC898.1 CGC908.1 CGC916.1 CGC921.1 CGC926.1 CGC955.1 CGC957.1 CGD063.1 CGD070.1 CGD076.1 CGD085.1 CGD101.1 CGD111.1 CGD119.1 CGD123.1 CGD192.1 CGD193.1 CGD220.1 CGD231.1 CGD240.1 CGD248.1 CGD251.1 CGD277.1 CGD278.1 CGD283.1 CGD308.1 CGD342.1 CGD343.1 CGD362.1 CGD694.1 CGD719.1 CGD739.1 CGD777.1 CGD790.1 CGD832.1 CGD892.1 CGG890.1 CGH131.1 CGH175.1 CGH183.1 CGH199.1 CGH245.1 CGH346.1 CGH413.1 CGL108.1 CGL207.1 CGL321.1 CGL863.1 CGL866.1 CGL889.1 CGP051.1 CGP078.1 CGP326.1 CGP615.1 CGS914.1 CGW231.1 CHB011.1 CHE598.1 CHE845.1 CHF161.1 CHF178.1 CHH717.1 CHH744.1 CHH773.1 CHJ032.1 CHK331.1 CHK354.1 CHK434.1 CHK648.1 CHM211.1 CHM389.1 CHM509.1 CHP603.1 CHP605.1 CHP621.1 CHR155.1 CHR240.1 CHT217.1 CHT238.1 CHT240.1 CHT241.1 CHT243.1 CHT245.1 CHT272.1 CHT356.1 CHT361.1 CHT373.1 CHT469.1 CHT478.1 CHT539.1 CHT553.1 CHT561.1 CHT589.1 CHT609.1 CHT624.1 CHT758.1 CHT815.1 CHT834.1 CHV674.1 CHV680.1 CHV710.1 CHV713.1 CHV794.1 CHV901.1 CHV989.1 CHW217.1 CHW262.1 CHW263.1 CHW306.1 CHW350.1 CHW362.1 CHW526.1 CHW560.1 CHW590.1 CHW591.1 CHW640.1 CHZ471.1 CHZ563.1 CHZ576.1 CJA246.1 CJG129.1 CJG177.1 CJM932.1 CJM940.1 CJN773.1 CJN780.1 CJN879.1 CJN987.1 CJP047.1 CJW418.1 CJW475.1 CJW534.1 CJW548.1 CJW586.1 CJX925.1 CJX962.1 CJX982.1 CJX986.1 CJY012.1 CJY075.1 CJY111.1 CJY226.1 CJY238.1 CJY304.1 CJY323.1 CJY360.1 CJY409.1 CJZ061.1 CJZ103.1 CJZ135.1 CJZ157.1 CJZ224.1 CJZ241.1 CJZ253.1 CJZ256.1 CJZ283.1 CJZ293.1 CJZ300.1 CJZ330.1 CJZ420.1 CJZ444.1 CJZ450.1 CKB402.1 CKB428.1 CKB439.1 CKB447.1 CKB487.1 CKB507.1 CKB608.1 CKB624.1 CKB654.1 CKB696.1 CKB725.1 CKB767.1 CKB887.1 CKD072.1 CKF569.1 CKF587.1 CKG394.1 CKG550.1 CKG586.1 CKG607.1 CKG915.1 CKG954.1 CKG956.1 CKG962.1 CKH467.1 CKH606.1 CKH692.1 CKH719.1 CKH736.1 CKH765.1 CKH774.1 CKH786.1 CKH815.1 CKH859.1 CKH923.1 CKL195.1 CKL217.1 CKL236.1 CKL295.1 CKL345.1 CKL464.1 CKL487.1 CKP251.1 CKP255.1 CKP277.1 CKP291.1 CKP393.1 CKP435.1 CKP483.1 CKP495.1 CKP563.1 CKP656.1 CKP678.1 CKP682.1 CKP717.1 CKP733.1 CKP803.1 CKP939.1 CKS483.1 CKS519.1 CKS531.1 CKS552.1 CKS588.1 CKS590.1 CKS616.1 CKS641.1 CKS662.1 CKS673.1 CKS684.1 CKS692.1 CKS698.1 CKS706.1 CKS827.1 CKS856.1 CKS869.1 CKS954.1 CKS986.1 CKS992.1 CKS994.1 CKS997.1 CKT159.1 CKY723.1 CKY781.1 CLC604.1 CLD150.1 CLD293.1 CLF739.1 CLF855.1 CLF880.1 CLF888.1 CLF901.1 CLG005.1 CLG094.1 CLG124.1 CLG391.1 CLG393.1 CLG395.1 CLG396.1 CLG423.1 CLG457.1 CLG534.1 CLK164.1

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 5 of 7

Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Z-2509-2023
Recall number
Z-2509-2023
Initiated
July 18, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Abbott Medical
Quantity
17,394 devices (US-12,134; OUS-5,260)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Code information

Model Number: 3664 UDI-DI Codes: 05415067020215 Serial Numbers: US AAP267.1 AAP380.1 ADJ914.1 ADN375.1 ADR612.1 ADR812.1 ADR986.1 ADS012.1 ADW504.1 ADW635.1 ADW707.1 ADW724.1 AEJ059.1 AEM902.1 AFB279.1 AFB934.1 AFG268.1 AFG350.1 AFG397.1 AFG464.1 AFG805.1 AFH541.1 AFH553.1 AFH568.1 AFH575.1 AFH576.1 AFH604.1 AFH613.1 AFH617.1 AFH639.1 AFH674.1 AFH677.1 AFH682.1 AFH703.1 AFZ616.1 AFZ687.1 AGA013.1 AGA017.1 AGA052.1 AGA096.1 AGM898.1 AGN323.1 AGU357.1 AHD751.1 AHD757.1 AHD776.1 AHK508.1 AHK532.1 AHK534.1 AHK572.1 AHK587.1 AHK590.1 AHK635.1 AHK638.1 AHK737.1 AHK983.1 AHK988.1 AHL190.1 AHV733.1 AHV737.1 AHV741.1 AHV948.1 AHW119.1 AHW230.1 AHW240.1 AHW254.1 AHW281.1 AHW322.1 AHW358.1 AHW386.1 AHW389.1 AHW399.1 AHW459.1 AHW487.1 AHW515.1 AHW533.1 AHW583.1 AHW624.1 AHW639.1 AHW652.1 AHW733.1 AJW507.1 AJW539.1 AJW598.1 AKB517.1 AKB528.1 AKB571.1 AKB573.1 AKB620.1 AKB627.1 AKB666.1 AKB734.1 AKB780.1 AKB856.1 AKB864.1 AKB876.1 AKB881.1 AKB951.1 AKB959.1 AKB962.1 AKB974.1 AKB975.1 AKB994.1 AKC002.1 AKC012.1 AKC028.1 AKC042.1 AKC049.1 AKC060.1 AKC064.1 AKC076.1 AKC111.1 AKC112.1 AKC123.1 AKC126.1 AKC136.1 AKC163.1 AKU509.1 AKU514.1 AKU522.1 AKU524.1 AKU527.1 AKU530.1 AKU538.1 AKU577.1 AKU593.1 AKU606.1 AKU625.1 AKU656.1 AKU668.1 AKU686.1 AKU693.1 AKU695.1 AKU713.1 AKU714.1 AKU716.1 AKU725.1 AKU731.1 AKU734.1 AKU737.1 AKU739.1 AKU760.1 AKU772.1 AKU798.1 AKU801.1 AKU806.1 AKU814.1 AKU836.1 AKU851.1 AKU862.1 AKU887.1 AKU890.1 AKU897.1 AKU911.1 AKU914.1 AKU920.1 AKU925.1 AKU931.1 AKU937.1 AKU947.1 AKU967.1 AKU971.1 AKU987.1 AKV004.1 AKV012.1 AKV016.1 AKV047.1 AKV050.1 AKV089.1 AKV090.1 AKV094.1 AKV096.1 AKV100.1 AKV114.1 AKV131.1 AKV137.1 AKV144.1 AKV147.1 AKV148.1 AKV157.1 AKV163.1 AKV168.1 AKV169.1 AKV173.1 AKV177.1 AKV188.1 AKV189.1 AKV199.1 AKV220.1 AKV228.1 AKV233.1 AKV242.1 AKV261.1 AKV265.1 AKV267.1 AKV270.1 AKV271.1 AKV274.1 AKV276.1 AKV277.1 AKV281.1 AKV284.1 AKV286.1 AKV292.1 AKV299.1 AKV300.1 AKV307.1 AKV318.1 AKV324.1 AKV335.1 AKV337.1 AKV350.1 AKV355.1 AKV358.1 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AXT363.1 AXT365.1 AXT366.1 AXT367.1 AXT368.1 AXT371.1 AXT372.1 AXT373.1 AXT374.1 AXT375.1 AXT377.1 AXT378.1 AXT379.1 AXT381.1 AXT382.1 AXT385.1 AXT387.1 AXT390.1 AXT393.1 AXT395.1 AXT396.1 AXT397.1 AXT398.1 AXT399.1 AXT402.1 AXT403.1 AXT406.1 AXT408.1 AXT409.1 AXT410.1 AXT412.1 AXT414.1 AXT416.1 AXT417.1 AXT419.1 AXT421.1 AXT425.1 AXT426.1 AXT428.1 AXT430.1 AXT433.1 AXT434.1 AXT435.1 AXT436.1 AXT437.1 AXT441.1 AXT442.1 AXT443.1 AXT445.1 AXT446.1 AXT447.1 AXT448.1 AXT452.1 AXT453.1 AXT459.1 AXT460.1 AXT461.1 AXT467.1 AXT468.1 AXT470.1 AXT471.1 AXT474.1 AXT475.1 AXT477.1 AXT478.1 AXT479.1 AXT480.1 AXT481.1 AXT483.1 AXT489.1 AXT490.1 AXT491.1 AXT494.1 AXT496.1 AXT497.1 AXT498.1 AXT502.1 AXT503.1 AXT504.1 AXT505.1 AXT507.1 AXT512.1 AXT513.1 AXT514.1 AXT516.1 AXT517.1 AXT519.1 AXT520.1 AXT521.1 AXT523.1 AXT524.1 AXT525.1 AXT526.1 AXT529.1 AXT530.1 AXT533.1 AXT534.1 AXT535.1 AXT539.1 AXT540.1 AXT544.1 AXT545.1 AXT546.1 AXT547.1 AXT548.1 AXT551.1 AXT553.1 AXT554.1 AXT555.1 AXT558.1 AXT559.1 AXT560.1 AXT562.1 AXT563.1 AXT564.1 AXT565.1 AXT568.1 AXV866.1 AXV868.1 AXV869.1 AXV870.1 AXV871.1 AXV872.1 AXV873.1 AXV874.1 AXV875.1 AXV876.1 AXV877.1 AXV878.1 AXV879.1 AXV880.1 AXV882.1 AXV883.1 AXV884.1 AXV885.1 AXV886.1 AXV887.1 AXV888.1 AXV890.1 AXV894.1 AXV901.1 AXV903.1 AXV907.1 AXV908.1 AXV909.1 AXV910.1 AXV912.1 AXV914.1 AXV916.1 AXV917.1 AXV918.1 AXV919.1 AXV920.1 AXV922.1 AXV923.1 AXV925.1 AXV926.1 AXV932.1 AXV934.1 AXV935.1 AXV936.1 AXV937.1 AXV941.1 AXV943.1 AXW024.1 AXW026.1 AXW027.1 AXW028.1 AXW029.1 AXW033.1 AXW038.1 AXW039.1 AXW040.1 AXW042.1 AXW045.1 AXW046.1 AXW048.1 AXW050.1 AXW051.1 AXW052.1 AXW053.1 AXW056.1 AXW059.1 AXW060.1 AXW063.1 AXW066.1 AXW071.1 AXW075.1 AXW076.1 AXW077.1 AXW078.1 AXW079.1 AXW080.1 AXW081.1 AXW082.1 AXW085.1 AXW088.1 AXW089.1 AXW093.1 AXW094.1 AXW096.1 AXW097.1 BBK869.1 BBK871.1 BBK872.1 BBK873.1 BBK874.1 BBK875.1 BBK878.1 BBK879.1 BBK880.1 BBK882.1 BBK883.1 BBK885.1 BBK887.1 BBK889.1 BBK898.1 BBK900.1 BBK901.1 BBK902.1 BBK903.1 BBK904.1 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BBW269.1 BBW273.1 BBW276.1 BBW277.1 BBW278.1 BBW280.1 BBW281.1 BBW285.1 BBW287.1 BBW290.1 BBW291.1 BBW292.1 BBW293.1 BBW294.1 BBW295.1 BBW296.1 BBW298.1 BBW300.1 BBW301.1 BBW302.1 BBW303.1 BBW304.1 BBW305.1 BBW307.1 BBW308.1 BBW309.1 BBW311.1 BBW312.1 BBW315.1 BBW316.1 BBW318.1 BBW323.1 BBW324.1 BBW325.1 BBW333.1 BBW336.1 BBW338.1 BBW339.1 BBW340.1 BBW343.1 BBW345.1 BBW346.1 BBW347.1 BBW348.1 BBW349.1 BBW352.1 BBW354.1 BBW357.1 BBW358.1 BBW361.1 BBW362.1 BBW363.1 BBW366.1 BBW367.1 BBW370.1 BBW374.1 BBW376.1 BBW383.1 BBW384.1 BBW385.1 BBW387.1 BBW388.1 BBW391.1 BBW392.1 BBW393.1 BBW396.1 BBW397.1 BBW398.1 BBW399.1 BBW400.1 BBW401.1 BBW402.1 BBW650.1 BBW652.1 BBW654.1 BBW655.1 BBW659.1 BBW660.1 BBW661.1 BBW663.1 BBW664.1 BBW667.1 BBW669.1 BBW672.1 BBW681.1 BBW684.1 BBW686.1 BBW687.1 BBW688.1 BBW690.1 BBW697.1 BBW700.1 BBW701.1 BBW704.1 BBW708.1 BBW713.1 BBW715.1 BBW716.1 BBW720.1 BBW721.1 BBW722.1 BBW725.1 BBW727.1 BBW728.1 BBW730.1 BBW732.1 BBW733.1 BBW735.1 BBW738.1 BBW739.1 BBW743.1 BBW747.1 BBW751.1 BBW752.1 BBW754.1 BBW755.1 BBW757.1 BBW759.1 BBW763.1 BBW764.1 BBW765.1 BBW766.1 BBW767.1 BBW768.1 BBW771.1 BBW772.1 BBW775.1 BBW777.1 BBW779.1 BBW789.1 BBW791.1 BBW792.1 BBW793.1 BBW798.1 BBW799.1 BBW803.1 BBW808.1 BBW809.1 BBW810.1 BBW811.1 BBW813.1 BBW816.1 BBW817.1 BBW820.1 BBW821.1 BBW822.1 BBW823.1 BBW825.1 BBW827.1 BBW828.1 BBW830.1 BBW832.1 BBW834.1 BBW838.1 BBW841.1 BBW847.1 BBW848.1 BBW849.1 BBW850.1 BBW851.1 BBW853.1 BBW856.1 BBW859.1 BBW860.1 BBW863.1 BBW864.1 BBW866.1 BBW868.1 BBW873.1 BBW875.1 BBW883.1 BBW885.1 BBW889.1 BBW890.1 BBW893.1 BBW897.1 BBW898.1 BBW901.1 BBW902.1 BBW903.1 BBW904.1 BBW906.

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 6 of 7

Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Z-2510-2023
Recall number
Z-2510-2023
Initiated
July 18, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Abbott Medical
Quantity
5,932 devices (US-4,464; OUS-1,468)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Code information

Model Number: 6660 UDI-DI Codes: 05415067030016 Serial Numbers: US AAD255.1 AAN997.1 AAP328.1 AAT540.1 AAT579.1 AAT652.1 AAT772.1 AAT783.1 AAT795.1 AAT797.1 AAT845.1 AAT902.1 AAT989.1 AAU009.1 AAU022.1 AAU046.1 AAU078.1 AAU094.1 ABM541.1 ABM592.1 ABM630.1 ABT798.1 ABT829.1 ABT841.1 ABT900.1 ACD800.1 ACE689.1 ACE771.1 ACE786.1 ACE838.1 ACE875.1 ACE936.1 ACE939.1 ACE994.1 ACF048.1 ACK145.1 ACK161.1 ACK241.1 ACK511.1 ACK514.1 ACK549.1 ACK622.1 ACK629.1 ACK637.1 ACK699.1 ACK702.1 ACK739.1 ACK752.1 ACK803.1 ACK805.1 ACK806.1 ACK828.1 ACK855.1 ACP686.1 ACP700.1 ACP712.1 ACP770.1 ACP780.1 ACP835.1 ACP869.1 ACP881.1 ACP883.1 ACT538.1 ACT548.1 ACT565.1 ACT738.1 ACU349.1 ACU381.1 ACU424.1 ADR673.1 ADR679.1 ADR685.1 ADR787.1 ADR794.1 ADR852.1 ADR856.1 ADW762.1 ADW766.1 ADW771.1 AEH704.1 AEH745.1 AEH748.1 AEH761.1 AEH764.1 AEH772.1 AEH826.1 AEH831.1 AEH856.1 AEH862.1 AEH865.1 AEH877.1 AEH883.1 AEH953.1 AEH955.1 AEH962.1 AEH972.1 AEJ054.1 AEJ100.1 AEJ101.1 AEJ111.1 AEJ145.1 AEJ164.1 AEJ167.1 AEJ196.1 AEJ203.1 AEJ241.1 AEJ251.1 AEJ252.1 AEJ257.1 AEM803.1 AEM833.1 AEM857.1 AEM877.1 AEM885.1 AEM887.1 AEM888.1 AEM951.1 AEM964.1 AEM967.1 AEM969.1 AEM988.1 AFB225.1 AFB349.1 AFB376.1 AFB425.1 AFB433.1 AFB434.1 AFB436.1 AFB444.1 AFB454.1 AFB495.1 AFB658.1 AFG344.1 AFG422.1 AFG446.1 AFG471.1 AFG496.1 AFG545.1 AFG668.1 AFG672.1 AFG679.1 AFG704.1 AFG724.1 AFG750.1 AFG810.1 AFG815.1 AFG819.1 AFG851.1 AFG852.1 AFG857.1 AFG871.1 AFG947.1 AFG959.1 AFZ148.1 AFZ174.1 AFZ198.1 AFZ211.1 AFZ224.1 AFZ260.1 AFZ359.1 AFZ364.1 AFZ384.1 AFZ392.1 AFZ409.1 AFZ530.1 AFZ532.1 AFZ590.1 AFZ807.1 AFZ835.1 AFZ851.1 AFZ996.1 AGM596.1 AGM602.1 AGM732.1 AGM764.1 AGM765.1 AGM950.1 AGN231.1 AGN324.1 AGN447.1 AGN552.1 AGN616.1 AHD578.1 AHD589.1 AHD612.1 AHD646.1 AHD648.1 AHD663.1 AHD677.1 AHD686.1 AHD713.1 AHD818.1 AHD821.1 AHK567.1 AHK727.1 AHK768.1 AHK778.1 AHK897.1 AHK906.1 AHK922.1 AHK976.1 AHL054.1 AHL069.1 AHL093.1 AHL095.1 AHL097.1 AHL105.1 AHL122.1 AHL133.1 AHL135.1 AHL138.1 AHL195.1 AHV587.1 AHV591.1 AHV705.1 AHV797.1 AHV801.1 AHV802.1 AHV807.1 AHV810.1 AHV818.1 AHV824.1 AHV843.1 AHV851.1 AHV854.1 AHV855.1 AHV860.1 AHV873.1 AHV887.1 AHV937.1 AHV945.1 AHV947.1 AHV965.1 AHV971.1 AHV975.1 AHV992.1 AHW055.1 AHW080.1 AHW082.1 AHW104.1 AHW496.1 AHW498.1 AHW661.1 AHW663.1 AHW670.1 AHW696.1 AJP994.1 AJP995.1 AJR053.1 AJR058.1 AJR073.1 AJR075.1 AJR076.1 AJR077.1 AJW278.1 AJW280.1 AJW285.1 AJW287.1 AJW290.1 AJW296.1 AJW310.1 AJW328.1 AJW329.1 AJW334.1 AJW336.1 AJW345.1 AJW365.1 AJW384.1 AJW388.1 AJW393.1 AJW412.1 AJW422.1 AJW431.1 AJW487.1 ALE668.1 ALE944.1 ALJ257.1 ALJ402.1 ALJ928.1 ALJ984.1 ALJ992.1 ALN367.1 ALN429.1 ALN438.1 ALN441.1 ALN444.1 ALN448.1 ALN451.1 ALN469.1 ALN477.1 ALN487.1 ALN547.1 ALN593.1 ALN596.1 ALN622.1 ALN658.1 ALX037.1 ALX043.1 ALX053.1 ALX085.1 ALX203.1 ALX313.1 ALY252.1 ALY270.1 ALY272.1 ALY313.1 ALY329.1 ALY367.1 ALY369.1 ALY371.1 ALY400.1 ALY431.1 ALY533.1 ALY541.1 ALY544.1 ALY610.1 ALY624.1 ALY625.1 ALY636.1 ALY653.1 ALY660.1 ALY774.1 ALY799.1 ALY801.1 ALY802.1 ALY810.1 ALZ051.1 ALZ080.1 ALZ174.1 ALZ191.1 ALZ311.1 AMJ759.1 AMK053.1 AMN778.1 AMN786.1 AMN800.1 AMN825.1 AMN826.1 AMN872.1 AMN919.1 AMN963.1 AMP153.1 AMP207.1 AMP263.1 AMP265.1 AMP271.1 AMS002.1 AMS004.1 AMS007.1 AMS022.1 AMS024.1 AMS026.1 AMS038.1 AMS068.1 AMS073.1 AMS126.1 AMS127.1 AMS161.1 AMS169.1 AMS193.1 AMS228.1 AMS241.1 AMS248.1 AMS256.1 AMS258.1 AMS259.1 AMS270.1 AMS400.1 AMS431.1 AMS445.1 AMS452.1 AMS480.1 AMS487.1 AMS488.1 AMS504.1 AMS678.1 AMS705.1 AMS817.1 AMS829.1 AMS854.1 AMS865.1 AMS867.1 AMS879.1 AMS889.1 AMS891.1 AMS892.1 AMS919.1 AMS920.1 AMS925.1 AMS928.1 AMS931.1 AMS939.1 AMS944.1 AMS946.1 AMS978.1 AMS983.1 AMS988.1 AMS989.1 AMS990.1 AMT006.1 AMT007.1 AMT018.1 AMT023.1 AMT027.1 AMT094.1 AMT114.1 AMT122.1 AMT212.1 AMT260.1 AMT275.1 AMT289.1 AMT292.1 AMT351.1 ANG899.1 ANG900.1 ANG969.1 ANG990.1 ANG999.1 ANH005.1 ANH036.1 ANH041.1 ANH056.1 ANH061.1 ANH062.1 ANH066.1 ANH075.1 ANH077.1 ANH094.1 ANH096.1 ANH100.1 ANH104.1 ANH110.1 ANH113.1 ANH123.1 ANH126.1 ANH127.1 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BVY308.1 BVY322.1 BVY366.1 BVY376.1 BVY407.1 BVY460.1 BVY492.1 BVY511.1 BVY527.1 BVY532.1 BVY560.1 BVY572.1 BVZ680.1 BVZ707.1 BVZ803.1 BVZ812.1 BVZ899.1 BVZ946.1 BVZ958.1 BVZ962.1 BVZ963.1 BWA048.1 BWA090.1 BWA110.1 BWA113.1 BWC135.1 BWC196.1 BWC315.1 BWC328.1 BWC377.1 BWC420.1 BWC422.1 BWC453.1 BWC462.1 BWC463.1 BWC472.1 BWC484.1 BWC553.1 BWC559.1 BWE769.1 BWE788.1 BWE842.1 BWE870.1 BWE903.1 BWE949.1 BWE953.1 BWE976.1 BWF046.1 BWF055.1 BWF064.1 BWF090.1 BWF091.1 BWF107.1 BWF128.1 BWF146.1 BWF148.1 BWF151.1 BWF229.1 BWF233.1 BWF257.1 BWF258.1 BWF265.1 BWF841.1 BWF843.1 BWF933.1 BWG022.1 BWG024.1 BWG066.1 BWG091.1 BWG108.1 BWG199.1 BWG355.1 BWG357.1 BWG367.1 BWJ623.1 BWJ659.1 BWJ682.1 BWJ727.1 BWJ777.1 BWJ802.1 BWJ859.1 BWJ904.1 BWJ942.1 BWK043.1 BWP103.1 BWP212.1 BWP274.1 BWP285.1 BWP289.1 BWP291.1 BWP337.1 BWP452.1 BWP559.1 BWP620.1 BWP623.1 BWP626.1 BWP643.1 BWP675.1 BWP688.1 BWP690.1 BWP760.1 BWP762.1 BWP768.1 BWP869.1 BWP877.1 BWP903.1 BWR039.1 BWT946.1 BWU031.1 BWU040.1 BWU057.1 BWV690.1 BWX122.1 BWX158.1 BWX212.1 BWX346.1 BXB034.1 BXB106.1 BXB174.1 BXB256.1 BXB265.1 BXB294.1 BXB377.1 BXB439.1 BXB583.1 BXB672.1 BXB726.1 BXB851.1 BXB902.1 BXC044.1 BXC086.1 BXC110.1 BXC121.1 BXH584.1 BXH594.1 BXH601.1 BXH616.1 BXH640.1 BXH655.1 BXH673.1 BXH744.1 BXH773.1 BXH776.1 BXH855.1 BXH858.1 BXH974.1 BXJ813.1 BXJ844.1 BXJ901.1 BXJ928.1 BXJ948.1 BXK035.1 BXK515.1 BXK573.1 BXK611.1 BXK707.1 BXK821.1 BXK833.1 BXK919.1 BXK926.1 BXL001.1 BXL012.1 BXM509.1 BXM570.1 BXM584.1 BXM671.1 BXM727.1 BXM761.1 BXM807.1 BXM859.1 BXM875.1 BXM920.1 BXM934.1 BXM955.1 BXN569.1 BXN695.1 BXN729.1 BXN774.1 BXN867.1 BXN877.1 BXN972.1 BXP041.1 BXP105.1 BXP113.1 BXR159.1 BXR190.1 BXS586.1 BXS717.1 BXS779.1 BXS846.1 BXS848.1 BXS887.1 BXT707.1 BXT715.1 BXT770.1 BXT787.1 BXT823.1 BXT828.1 BXT840.1 BXT851.1 BXV957.1 BXV969.1 BXW203.1 BXW302.1 BXW478.1 BXY564.1 BXY591.1 BXY626.1 BXY646.1 BXY665.1 BXY806.1 BXY814.1 BXY816.1 BXY897.1 BXY898.1 BXY919.1 BYA223.1 BYA283.1 BYA289.1 BYB676.1 BYB678.1 BYB685.1 BYD752.1 BYD756.1 BYD798.1 BYD820.1 BYD844.1 BYE015.1 BYE077.1 BYE083.1 BYE103.1 BYE134.1 BYE149.1 BYE168.1 BYE181.1 BYE208.1 BYE242.1 BYE260.1 BYE262.1 BYE385.1 BYE410.1 BYE483.1 BYE527.1 BYG537.1 BYG590.1 BYG620.1 BYL765.1 BYL782.1 BYL807.1 BYL848.1 BYL860.1 BYL912.1 BYL924.1 BYL934.1 BYL945.1 BYL958.1 BYL959.1 BYL961.1 BYL968.1 BYM066.1 BYM104.1 BYM126.1 BYM188.1 BYP305.1 BYP334.1 BYP341.1 BYP348.1 BYP355.1 BYP369.1 BYP412.1 BYP425.1 BYP431.1 BYR162.1 BYR259.1 BYR330.1 BYR484.1 BYR499.1 BYR513.1 BYS448.1 BYS459.1 BYS533.1 BYS583.1 BYS591.1 BYS593.1 BYS618.1 BYS650.1 BYS653.1 BYU021.1 BYU132.1 BYU399.1 BYU410.1 BYU450.1 BYU453.

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 7 of 7

Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Z-2511-2023
Recall number
Z-2511-2023
Initiated
July 18, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Abbott Medical
Quantity
16,395 devices (US-7,793; OUS-8,602)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Code information

Model Number: 6662 UDI-DI Codes: 05415067030023 Serial Numbers: US AAD298.1 AAP149.1 AAP193.1 AAU029.1 ABA964.1 ABM581.1 ABM600.1 ABT745.1 ABT832.1 ABT883.1 ACD617.1 ACD686.1 ACD772.1 ACD773.1 ACD797.1 ACE661.1 ACK379.1 ACK583.1 ACK784.1 ACK837.1 ACP794.1 ACT645.1 ACT654.1 ACT684.1 ACT737.1 ACT796.1 ACT895.1 ACU006.1 ACU060.1 ACU081.1 ACU085.1 ACU091.1 ACU165.1 ACU220.1 ACU247.1 ADD484.1 ADD593.1 ADD635.1 ADD647.1 ADD673.1 ADD681.1 ADD754.1 ADD785.1 ADD792.1 ADD904.1 ADD905.1 ADD910.1 ADD946.1 ADD947.1 ADD970.1 ADD995.1 ADE002.1 ADE014.1 ADE027.1 ADE030.1 ADE032.1 ADE073.1 ADE100.1 ADE105.1 ADE129.1 ADE144.1 ADE152.1 ADJ719.1 ADK216.1 ADK277.1 ADN241.1 ADR337.1 ADR349.1 ADR353.1 ADR399.1 ADR432.1 ADR435.1 ADR452.1 ADR467.1 ADR522.1 ADR545.1 ADR604.1 ADR636.1 ADR662.1 ADR680.1 ADR682.1 ADR705.1 ADR813.1 ADR815.1 ADR829.1 ADR841.1 ADR924.1 ADR945.1 ADR951.1 ADR984.1 ADR985.1 ADW488.1 ADW495.1 ADW497.1 ADW520.1 ADW561.1 ADW566.1 ADW615.1 ADW675.1 ADW699.1 ADW720.1 ADW725.1 ADW728.1 ADW749.1 ADW754.1 ADW759.1 ADW767.1 ADW781.1 ADW790.1 ADW872.1 ADW912.1 ADW935.1 ADW983.1 ADW998.1 AEH631.1 AEH637.1 AEH644.1 AEH651.1 AEH654.1 AEH657.1 AEH670.1 AEH680.1 AEH699.1 AEH700.1 AEH702.1 AEH711.1 AEH714.1 AEH721.1 AEH723.1 AEH729.1 AEH730.1 AEH746.1 AEH815.1 AEH821.1 AEH825.1 AEH851.1 AEH853.1 AEH872.1 AEH875.1 AEH898.1 AEH938.1 AEH960.1 AEJ005.1 AEJ033.1 AEJ039.1 AEJ049.1 AEJ066.1 AEJ097.1 AEJ103.1 AEJ121.1 AEJ134.1 AEJ136.1 AEJ142.1 AEJ149.1 AEJ151.1 AEJ189.1 AEJ194.1 AEJ214.1 AEJ243.1 AEM754.1 AEM767.1 AEM777.1 AEM791.1 AEM795.1 AEM797.1 AEM820.1 AEM851.1 AEM867.1 AEM889.1 AEM918.1 AEM972.1 AEM975.1 AEN031.1 AFB394.1 AFB395.1 AFB396.1 AFB404.1 AFB446.1 AFB903.1 AFB924.1 AFB946.1 AFG274.1 AFG376.1 AFG413.1 AFG429.1 AFG431.1 AFG447.1 AFG451.1 AFG452.1 AFG473.1 AFG488.1 AFG535.1 AFG560.1 AFG652.1 AFG658.1 AFG663.1 AFG682.1 AFG689.1 AFG707.1 AFG742.1 AFG807.1 AFG823.1 AFG846.1 AFG889.1 AFG895.1 AFG926.1 AFZ158.1 AFZ168.1 AFZ178.1 AFZ180.1 AFZ185.1 AFZ197.1 AFZ208.1 AFZ320.1 AFZ331.1 AFZ362.1 AFZ363.1 AFZ373.1 AFZ377.1 AFZ400.1 AFZ435.1 AFZ442.1 AFZ446.1 AFZ448.1 AFZ449.1 AFZ454.1 AFZ651.1 AFZ674.1 AHK715.1 AHW013.1 AKB668.1 AKU960.1 AKV412.1 AKV505.1 AKV522.1 AKV579.1 AKV612.1 AKX057.1 AKX078.1 AKX170.1 AKX201.1 AKX211.1 AKX233.1 AKX245.1 AKX266.1 AKX268.1 AKX351.1 AKX374.1 AKX384.1 AKX430.1 AKX434.1 AKX549.1 AKX690.1 AKX715.1 AKX739.1 AKX748.1 AKX750.1 AKX775.1 ALE569.1 ALE584.1 ALE588.1 ALE603.1 ALE604.1 ALE605.1 ALE624.1 ALE631.1 ALE675.1 ALE753.1 ALE774.1 ALE833.1 ALE881.1 ALE931.1 ALE956.1 ALF015.1 ALF030.1 ALF137.1 ALF156.1 ALF174.1 ALF176.1 ALF177.1 ALJ221.1 ALJ273.1 ALJ293.1 ALJ294.1 ALJ296.1 ALJ336.1 ALJ360.1 ALJ403.1 ALJ410.1 ALJ411.1 ALJ917.1 ALJ936.1 ALJ943.1 ALJ954.1 ALJ958.1 ALJ995.1 ALK043.1 ALN346.1 ALN365.1 ALN387.1 ALN401.1 ALN410.1 ALN416.1 ALN423.1 ALN466.1 ALN475.1 ALN484.1 ALN518.1 ALN543.1 ALN601.1 ALN605.1 ALN609.1 ALN624.1 ALN670.1 ALN672.1 ALN680.1 ALN701.1 ALN703.1 ALN708.1 ALX018.1 ALX040.1 ALX048.1 ALX114.1 ALX116.1 ALX118.1 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ANG949.1 ANG980.1 ANH007.1 ANH074.1 ANH117.1 ANH154.1 ANH156.1 ANH224.1 ANH234.1 ANH333.1 ANH344.1 ANH358.1 ANH367.1 ANH373.1 ANH390.1 ANH399.1 ANH401.1 ANH402.1 ANH413.1 ANH416.1 ANH434.1 ANH451.1 ANH540.1 ANH619.1 ANH647.1 ANL421.1 ANL432.1 ANL459.1 ANL514.1 ANL623.1 ANL767.1 ANL799.1 ANL810.1 ANL814.1 ANL971.1 ANM009.1 ANM047.1 ANM057.1 ANM075.1 ANT216.1 ANT230.1 ANT237.1 ANT270.1 ANT454.1 ANT462.1 ANT672.1 ANT708.1 ANT732.1 ANT737.1 ANT758.1 ANT776.1 APA921.1 APB243.1 APB252.1 APB357.1 APB553.1 APB588.1 APB626.1 APB818.1 APL320.1 APL634.1 APS407.1 APZ740.1 ARG324.1 ARJ147.1 ARK173.1 ARK424.1 ARK511.1 ARK733.1 ARK802.1 ARK815.1 ARK913.1 ARL115.1 ARL249.1 ASG447.1 ASG458.1 ASG563.1 ASG582.1 ASG600.1 ASG617.1 ASG622.1 ASG629.1 ASG642.1 ASG649.1 ASG746.1 ASG752.1 ASG770.1 ASG916.1 ASJ231.1 ASJ252.1 ASJ274.1 ASL986.1 ASM010.1 ASM186.1 ASM270.1 ASM283.1 ASM284.1 ASM309.1 ASM326.1 ASM338.1 ASM383.1 ASM439.1 ASR473.1 ASR555.1 ASR570.1 ASR785.1 ASR964.1 ASV494.1 ASV610.1 ASV891.1 ASV912.1 ASW211.1 ATC690.1 ATC698.1 ATD017.1 ATD019.1 ATD053.1 ATD085.1 ATD112.1 ATD180.1 ATD191.1 ATD410.1 ATD434.1 ATD494.1 ATD595.1 ATD687.1 ATD692.1 ATD709.1 ATD742.1 ATD807.1 ATD809.1 ATD877.1 ATD928.1 ATD944.1 ATD952.1 ATE654.1 ATE664.1 ATE665.1 ATE756.1 ATE880.1 ATE911.1 ATE932.1 ATE936.1 ATF057.1 ATF069.1 ATF287.1 ATF315.1 ATF350.1 ATF398.1 ATF410.1 ATF411.1 ATF433.1 ATF440.1 ATJ812.1 ATJ826.1 ATJ880.1 ATJ957.1 ATJ992.1 ATK084.1 ATK101.1 ATK107.1 ATK111.1 ATK157.1 ATK224.1 ATK267.1 ATK274.1 ATK312.1 ATT927.1 ATT956.1 ATT959.1 ATU003.1 ATU006.1 ATU014.1 ATU041.1 ATU043.1 ATU047.1 ATU056.1 ATU058.1 ATU060.1 ATU108.1 ATU236.1 ATU238.1 ATU256.1 ATU259.1 ATU278.1 ATU354.1 ATU371.1 ATU373.1 ATU394.1 ATU396.1 ATU399.1 ATU443.1 ATU447.1 ATU456.1 ATU468.1 ATU477.1 ATU479.1 ATU484.1 ATU493.1 ATU515.1 ATU521.1 ATU522.1 ATU523.1 ATU524.1 ATU527.1 ATU545.1 ATU549.1 ATU553.1 ATU558.1 ATU572.1 ATU589.1 ATU602.1 ATU611.1 ATU697.1 ATU701.1 ATU702.1 ATU720.1 ATU730.1 ATU740.1 ATU815.1 ATU833.1 ATU862.1 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BKF737.1 BKF751.1 BKF776.1 BKF779.1 BKF892.1 BKF907.1 BKF916.1 BKG005.1 BKG009.1 BKG016.1 BKG020.1 BKG037.1 BKG087.1 BKG114.1 BKG115.1 BKG126.1 BKG165.1 BKG217.1 BKG370.1 BKH631.1 BKH907.1 BKH911.1 BKH936.1 BKH966.1 BKH968.1 BKJ084.1 BKJ091.1 BKJ114.1 BKJ128.1 BKJ143.1 BKJ154.1 BKJ170.1 BKJ181.1 BKJ323.1 BKJ332.1 BKJ341.1 BKJ348.1 BKJ351.1 BKJ355.1 BKJ389.1 BKS897.1 BKS901.1 BKT061.1 BKT070.1 BKT104.1 BKT234.1 BKT241.1 BKT386.1 BKT395.1 BKT565.1 BKZ214.1 BKZ215.1 BKZ409.1 BLA375.1 BLA393.1 BLA439.1 BLA447.1 BLA448.1 BLA457.1 BLA556.1 BLA624.1 BLA636.1 BLA639.1 BLA647.1 BLA652.1 BLA667.1 BLA668.1 BLA672.1 BLA682.1 BLA706.1 BLA709.1 BLA714.1 BLA718.1 BLA838.1 BLA844.1 BLA926.1 BLA929.1 BLA934.1 BLC290.1 BLC316.1 BLC333.1 BLC338.1 BLC353.1 BLC370.1 BLC395.1 BLC438.1 BLC453.1 BLC466.1 BLC482.1 BLC485.1 BLC489.1 BLC503.1 BLC516.1 BLC521.1 BLC527.1 BLC543.1 BLC597.1 BLC600.1 BLC628.1 BLC661.1 BLC671.1 BLC813.1 BLC825.1 BLC853.1 BLK385.1 BLK404.1 BLK449.1 BLK468.1 BLK474.1 BLK487.1 BLK522.1 BLK526.1 BLK527.1 BLK538.1 BLK587.1 BLK594.1 BLK618.1 BLK619.1 BLK654.1 BLK666.1 BLK672.1 BLK711.1 BLK721.1 BLK767.1 BLK785.1 BLK804.1 BLK812.1 BLK822.1 BLK833.1 BLK893.1 BLK919.1 BLK923.1 BLK935.1 BLK950.1 BLL033.1 BLL034.1 BLL099.1 BLL143.1 BLL194.1 BLL221.1 BLP001.1 BLP016.1 BLP101.1 BLP116.1 BLP139.1 BLP176.1 BLP182.1 BLP183.1 BLP204.1 BLP216.1 BLP217.1 BLP249.1 BLP253.1 BLP282.1 BLP338.1 BLP365.1 BLP389.1 BLP411.1 BLP445.1 BLP469.1 BLP492.1 BLP499.1 BLP510.1 BLP587.1 BLP593.1 BLP615.1 BLP633.1 BLP663.1 BLT660.1 BLT923.1 BLY123.1 BLY587.1 BLY637.1 BLY710.1 BLY716.1 BLY740.1 BLY823.1 BLY877.1 BLY880.1 BLY881.1 BLY893.1 BLY954.1 BLY970.1 BLY984.1 BLZ054.1 BLZ104.1 BLZ115.1 BLZ148.1 BLZ157.1 BLZ172.1 BLZ204.1 BLZ206.1 BLZ215.1 BLZ227.1 BLZ254.1 BLZ309.1 BMA867.1 BMA870.1 BMA898.1 BMA927.1 BMB012.1 BMB015.1 BMB031.1 BMB895.1 BMB930.1 BMB954.1 BMB958.1 BMB984.1 BMC014.1 BMC016.1 BMC019.1 BMC031.1 BMC045.1 BMC055.1 BMC114.1 BMC129.1 BMC131.1 BMC132.1 BMC268.1 BMC270.1 BMC284.1 BMC287.1 BMC326.1 BMC363.1 BMC381.1 BMC382.1 BMC399.1 BMC403.1 BMC417.1 BMC420.1 BMC421.1 BMC428.1 BMC473.1 BMD817.1 BMD823.1 BMD870.1 BMD876.1 BMD877.1 BMD887.1 BMD900.1 BMD906.1 BMD934.1 BMD936.1 BMD951.1 BMD976.1 BMD986.1 BME032.1 BME034.1 BME037.1 BME039.1 BME043.1 BME047.1 BMF601.1 BMF609.1 BMF611.1 BMF658.1 BMF673.1 BMF674.1 BMF675.1 BMF678.1 BMF703.1 BMF731.1 BMF766.1 BMF805.1 BMF807.1 BMF811.1 BMF814.1 BMF853.1 BMF867.1 BMF877.1 BMF898.1 BMF906.1 BMF909.1 BMF921.1 BMF922.1 BMF934.1 BMF938.1 BMF992.1 BMF996.1 BMG009.1 BMG016.1 BMG063.1 BMG112.1 BMG125.1 BMG127.1 BMG135.1 BMG139.1 BMG143.1 BMG170.1 BMG173.1 BMG184.1 BMG205.1 BMG227.

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.